How to create an FDA Prior Notice when shipping items from Canada to the U.S. – Sendle Support CA

Note: Shipping FDA regulated items from CA to U.S. is available for Sendle business customers only.

Shipping FDA-regulated items from Canada to the U.S.? You must submit an FDA Prior Notice before your package is sent. This ensures compliance with U.S. import regulations and helps your shipment clear customs smoothly.

Follow this step-by-step guide to create and attach your FDA Prior Notice.

Step 1: Determine if your shipment requires prior notice

FDA Prior Notice is required for consumables and other FDA-regulated items. Check the FDA website to confirm whether your shipment needs one and don’t forget to compare it with Sendle’s guidelines on what you can’t Sendle.

Step 2: Fill in your FDA Prior Notice

Log in or create an account if you don’t have one.
You will be guided through the Prior Notice System Interface (PNSI) and asked to enter details about your shipment.

Heads up: You can view a step-by-step video tutorial on the FDA website.

Here’s a summary of what you’ll need:

✅ Shipment details

Customs Entry Number (if you don't have one, select 'No' and the system will generate one for you)
How it’s getting there (answer: Land, Truck)
Where it’s arriving (port of entry) Use our port of arrival database to determine which 'state' and 'port of arrival' to list on your Prior Notice. Feel free to download and print our database for your reference.)
Arrival date and time (this is the same as your Sendle scheduled pick up date and you should use 17:00 as the time)

✅ Who’s involved

Your contact details
Importer’s name and address
Ultimate consignee (final recipient)

✅ About the consumables

FDA Product Code (or search by product name)
What it is (common or market name)
Lot/production codes (if available)
Quantity and packaging info

✅ Where it’s coming from

Manufacturer’s details (name, address, FDA registration number if available)
Shipper’s details
Who owns it and who’s receiving it
If fresh produce: Grower/consolidator details

✅ Other important info

Has this product been refused entry by another country?
Is it bulk or packaged?
If required: Holding facility details (location and contact info)

Step 3: Submit your FDA Prior Notice

You will be asked to submit the form and download the PDF of your Prior Notice confirmation.

Step 4: Print the Prior Notice

Print the FDA Prior Notice on a U.S. letter size (8.5 x 11-inch) sheet of paper.
If you're shipping multiple packages containing FDA-regulated items, you can print multiple copies of the same Prior Notice – just make sure each package has a copy attached.

Step 5: Attach the Prior Notice to your shipment

Place the printed Prior Notice in a clear packing list envelope (such as these).
Securely attach the envelope to the outside of your package.
If folding the Prior Notice, ensure that the barcodes remain visible for easy scanning.

Step 6: Ship your package

Once your FDA Prior Notice is attached, your package is ready for Sendle pickup. Make sure your shipment details match what was submitted in the Prior Notice to avoid delays.

Check out our guide on Shipping consumables from Canada to the U.S. for more information on shipping FDA-regulated items.

Need more help?

If you're unsure of anything you can contact the FDA directly You will find contact details (email and phone number) towards the bottom of the page – keep scrolling until you find the blue box!